DRX-COMPASS X-RAY SYSTEM recallZ-1206-2023 · Carestream Health, Inc. · initiated Jan 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carestream Health, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury
FDA root cause category: Software design
What the company is doing
Carestream issued Urgent Medical Device Correction Letter to Director of Radiology, Chief Radiology Administrator and DRX-Compass/DR-FIT X-ray System Administrators (US) consignees on 1/30/23. Letter states reason for recall, health risk and action to take: Do not use the Z-Axis Motorized button on the Tube Head Display at this time. Use the Brake Release buttons (Items 5 or 8) to manually move the OTC in the Z-Axis. " Press any E-stop button to stop unexpected movement immediately. " A Service Representative will install a Firmware correction. Action to be taken: A Carestream Service Engineer or Carestream Health Authorized Representative will contact your site and setup a service call to inspect your device and install a new firmware version. For your convenience, a Notification Acknowledgement form has been provided with this letter. Please read and complete the information within 5 working days. Remit the completed form by e-mail to: [email protected]. Questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Carestream S vice support number
Recall details
- Recall number
- Z-1206-2023
- Status
- Open, Classified
- Initiated by the company
- Jan 30, 2023
- Posted by the FDA
- Mar 2, 2023
- Recalling firm
- Carestream Health, Inc.
- Quantity
- 72 units
- Product code
- KPR
- FDA submissions
- K201373
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of California, Idaho, Illinois, Massachusetts, Minnesota, Nevada, North Carolina, Texas Wisconsin and the countries of Argentina, Australia, Brazil, China, Finland, France, INDIA, ITALY, Korea, Malaysia, Poland, Republic of Korea.
Product description
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).
Code information (models, lots, serial numbers)
UDI: 60889978621613 (Rayco) 60889978624188 (1049) US Serial Numbers: SP0763 50066 50082 50089 50135 50145 50143 50140D 50144 OUS serial numbers: SP0819 SP0687G2 SP0726 SP0746 SP0834 SP0837 S0001 S0170 S0698G2 1085 FS0564 S0578 S0744 SP0903 SP0600 SP1035 SP0930 SP1007 SP1037 SP0772 S0934G2 S0639G2 S1020G2 S0118 S0135 S0134 S0165 S0167 S0168 S0181 S0800G2 S0784G2 S0811G2 S0832G2 S0826G2 S0822G2 S1038G2 S0678G2 S0619G2 S0636G2 S0641G2 S0643G2 S0701G2 S0738G2 S0758G2 S0760G2 S0673G2 S0785G2 S0842G2 S0860G2 S0863G2 S0888G2 S0973G2 S1105G2 S1048G2 S1073G2 S1004G2 S1110G2 S0791G2 S0941G2 SP0900 S0625
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DRX-Compass X-ray SystemCarestream Health, Inc. · System, x-ray, stationary1 recall2 reports
- DRX-COMPASS X-RAY SYSTEMCarestream Health, Inc. · System, x-ray, stationary1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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